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A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female cigarette smokers between the ages of 18 and 75 years, inclusive, who
are motivated to stop smoking.

- Females of non-childbearing potential (surgically sterilized or at least 2 years
postmenopausal) who are not nursing may be included.

- Subjects must have smoked an average of at least 10 cigarettes per day during the past
year and over the month prior to the screening visit, with no period of abstinence
greater than 3 months in the past year.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects with clinically significant cardiovascular disease in the past 6 months.

- Subjects hospitalized within the past 12 months due to suicidal ideation or suicidal
behavior or subjects considered to have serious suicidal ideation or suicidal behavior
within the past 12 months.

- Subjects having active suicidal ideation or behavior identified at Screen or Baseline.

- Subjects currently or within the past 12 months requiring treatment for depression.
Subjects with current or prior history of panic disorder, anxiety disorder, hostility
or aggression disorder, perceptual/thinking disturbances, psychosis, or bipolar
disorder.

NCT00741884
Pfizer
Withdrawn
A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation

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A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation
A Phase 2, Seven Week, Double-Blind, Placebo Controlled, Randomized, Parallel Group Study To Evaluate The Safety And Efficacy Of Three Doses Of A Controlled Release Formulation Of Varenicline For Smoking Cessation
The purpose of this study is to evaluate the safety, efficacy, and tolerability of twice daily (BID) administration of three dose strengths (1.2 mg, 1.8 mg, and 2.4 mg) of varenicline controlled release (CR) tablets in adult smokers.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Smoking Cessation
  • Drug: Varenicline Controlled Release 1.2 mg
    Varenicline CR tablet 1.2 mg BID for 7 weeks
  • Drug: Varenicline Controlled Release 1.8 mg
    Varenicline CR tablet 1.8 mg BID for 7 weeks
  • Drug: Varenicline Controlled Release 2.4 mg
    Varenicline CR tablet 2.4 mg BID for 7 weeks
  • Drug: Varenicline Immediate Release 1 mg
    Varenicline IR tablet 1 mg BID for 7 weeks
  • Drug: Placebo
    Placebo BID for 7 weeks
  • Experimental: Arm 1
    Intervention: Drug: Varenicline Controlled Release 1.2 mg
  • Experimental: Arm 2
    Intervention: Drug: Varenicline Controlled Release 1.8 mg
  • Experimental: Arm 3
    Intervention: Drug: Varenicline Controlled Release 2.4 mg
  • Active Comparator: Arm 4
    Intervention: Drug: Varenicline Immediate Release 1 mg
  • Placebo Comparator: Arm 5
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female cigarette smokers between the ages of 18 and 75 years, inclusive, who are motivated to stop smoking.
  • Females of non-childbearing potential (surgically sterilized or at least 2 years postmenopausal) who are not nursing may be included.
  • Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

  • Subjects with clinically significant cardiovascular disease in the past 6 months.
  • Subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past 12 months.
  • Subjects having active suicidal ideation or behavior identified at Screen or Baseline.
  • Subjects currently or within the past 12 months requiring treatment for depression. Subjects with current or prior history of panic disorder, anxiety disorder, hostility or aggression disorder, perceptual/thinking disturbances, psychosis, or bipolar disorder.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00741884
A3051090
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]



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